Adaptive seamless design for an efficacy trial of replication-competent adenovirus-mediated suicide gene therapy and radiation in newly-diagnosed prostate cancer (ReCAP Trial)

Contemporary Clinical Trials

Volumn 32, Issue 3, 2011, Pages 453-460

  Lu, Mei ^a   Freytag, Svend O ^a   Stricker, Hans ^b   Kim, Jae Ho ^a   Barton, Kenneth ^a   Movsas, Benjamin ^a  

^a Department of Public Health Sciences ^*  (United States)

^b HENRY FORD HEALTH SYSTEM   (United States)

Author keywords

Adaptive design; Interim analysis; Prostate cancer

Indexed keywords

AD5 YCD/MUTTK SR39 REP ADP ADENOVIRUS VECTOR; CONDITIONALLY REPLICATING ADENOVIRUS; FLUCYTOSINE; UNCLASSIFIED DRUG; VALGANCICLOVIR;

ADULT; ARTICLE; CONTROLLED STUDY; FOOD AND DRUG ADMINISTRATION; HUMAN; INTENSITY MODULATED RADIATION THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PROSTATE BIOPSY; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STUDY DESIGN; SUICIDE GENE THERAPY;

ADENOVIRIDAE; ANTIMETABOLITES; ANTIVIRAL AGENTS; COMBINED MODALITY THERAPY; FLUCYTOSINE; GANCICLOVIR; GENE THERAPY; GENES, TRANSGENIC, SUICIDE; GENETIC VECTORS; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; PROSTATIC NEOPLASMS; QUALITY OF LIFE; RADIOTHERAPY, INTENSITY-MODULATED; SAMPLE SIZE; TREATMENT OUTCOME; VIRUS REPLICATION;

EID: 79953056388     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2011.01.013     Document Type: Article

References (34)

1. Pollack A., Zagars G.K., Starkschall G., Antolak J.A., Lee J.J., Huang E., et al. Prostate cancer radiation dose response: results of the M.D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys 2002, 53:1097-1105.
2. Zietman A.L., DeSilvio M.L., Slater J.D., Rossi C.J., Miller D.W., Adams J.A., et al. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA 2005, 294:1233-1239.
3. Bolla M., Gonzalez D., Warde P., Dubois J.B., Mirimanoff R.O., Storme G., et al. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med 1997, 337:295-300.
4. D'Amico A.V., Manola J., Loffredo M., Renshaw A.A., DellaCroce A., Kantoff P.W. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA 2004, 292:821-827.
5. Holzbeierlein J.M., Castle E., Thrasher J.B. Complications of androgen deprivation therapy: prevention and treatment. Oncol Williston Park 2004, 18:303-309.
6. Sanda M.G., Dunn R.L., Michalski J., Sandler H.M., Northouse L., Hembroff L., et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med 2008, 358:1250-1261.
7. Freytag S.O., Rogulski K.R., Paielli D.L., Gilbert J.D., Kim J.H. A novel three-pronged approach to kill cancer cells selectively: concomitant viral, double suicide gene, and radiotherapy. Hum Gene Ther 1998, 9:1323-1333.
8. Freytag S.O., Movsas B., Aref I., Stricker H., Peabody J., Pegg J., et al. Phase I trial of replication-competent adenovirus-mediated suicide gene therapy combined with IMRT for prostate cancer. Mol Ther 2007, 15:1016-1023.
9. Freytag S.O., Stricker H., Movsas B., Kim J.H. Prostate cancer gene therapy clinical trials. Mol Ther 2007, 15:1042-1052.
10. Gallo P., Chuang-Stein C., Dragalin V., Gaydos B., Krams M., Pinheiro J. Adaptive designs in clinical drug development - an executive summary of the PhRMA working group. J Biopharm Stat 2006, 16:275-283.
11. Kuehn B.M. Industry, FDA warm to "adaptive" trials. JAMA 2006, 296:1955-1957.
12. Gallo P., Maurer W. Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians. Biom J 2006, 48:591-597.
13. Spalding A.C., Daignault S., Sandler H.M., Shah R.B., Pan C.C., Ray M.E. Percent positive biopsy cores as a prognostic factor for prostate cancer treated with external beam radiation 2. Urology 2007, 69:936-940.
14. Horwitz E.M., Thames H.D., Kuban D.A., Levy L.B., Kupelian P.A., Martinez A.A., et al. Definitions of biochemical failure that best predict clinical failure in patients with prostate cancer treated with external beam radiation alone: a multi-institutional pooled analysis. J Urol 2005, 173:797-802.
15. Wei J.T., Dunn R.L., Litwin M.S., Sandler H.M., Sanda M.G. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology 2000, 56:899-905.
16. Rabin R., De C.F. EQ-5D: a measure of health status from the EuroQol group. Ann Med 2001, 33:337-343.
17. O'Brien P.C., Fleming T. A multiple testing procedure for clinical trials. Biomatric 1979, 35:549-556.
18. Lan K., DeMets D. Discrete sequential boundaries for clinical trials. Bimmetrika 1983, 70:659-663.
19. Newman T.B. If almost nothing goes wrong, is almost everything all right? Interpreting small numerators, 2. JAMA 1995, 274:1013.
20. Pollack A., Zagars G.K., Smith L.G., Lee J.J., von Eschenbach A.C., Antolak J.A., et al. G. Starkschall, and I. Rosen, Preliminary results of a randomized radiotherapy dose-escalation study comparing 70Gy with 78Gy for prostate cancer. J Clin Oncol 2000, 18:3904-3911.
21. Pollack A., Zagars G.K., Antolak J.A., Kuban D.A., Rosen I.I. Prostate biopsy status and PSA nadir level as early surrogates for treatment failure: analysis of a prostate cancer randomized radiation dose escalation trial. Int J Radiat Oncol Biol Phys 2002, 54:677-685.
22. Rothman K., Greenland S. Modern Epidemiology 1998, Lippincott-Raven, Philadelphia.
23. FDA. Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologics (DRAFT GUIDANCE). 2010.
24. Pound C.R., Partin A.W., Eisenberger M.A., Chan D.W., Pearson J.D., Walsh P.C. Natural history of progression after PSA elevation following radical prostatectomy. JAMA 1999, 281:1591-1597.
25. Renshaw A.A., Schultz D., Cote K., Loffredo M., Ziemba D.E., D'Amico A.V. Accurate Gleason grading of prostatic adenocarcinoma in prostate needle biopsies by general pathologists. Arch Pathol Lab Med 2003, 127:1007-1008.
26. Sandler H.M., DeSilvio M.L. Surrogate end points for prostate cancer: what is prostate-specific antigen telling us?. J Natl Cancer Inst 2003, 95:1352-1353.
27. Collette L. Prostate-specific antigen (PSA) as a surrogate end point for survival in prostate cancer clinical trials. Eur Urol 2008, 53:6-9.
28. Kuban D.A., Tucker S.L., Dong L., Starkschall G., Huang E.H., Cheung M.R., et al. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys 2008, 70:67-74.
29. Valicenti R.K., DeSilvio M., Hanks G.E., Porter A., Brereton H., Rosenthal S.A., et al. Posttreatment prostatic-specific antigen doubling time as a surrogate endpoint for prostate cancer-specific survival: an analysis of Radiation Therapy Oncology Group Protocol 92-02. Int J Radiat Oncol Biol Phys 2006, 66:1064-1071.
30. Peeters S.T., Heemsbergen W.D., Koper P.C., van Putten W.L., Slot A., Dielwart M.F., et al. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68Gy of radiotherapy with 78Gy. J Clin Oncol 2006, 24:1990-1996.
31. Wong W.W., Schild S.E., Vora S.A., Halyard M.Y. Association of percent positive prostate biopsies and perineural invasion with biochemical outcome after external beam radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys 2004, 60:24-29.
32. Vance W., Tucker S.L., de C.R., Kuban D.A., Cheung M.R. The predictive value of 2-year posttreatment biopsy after prostate cancer radiotherapy for eventual biochemical outcome. Int J Radiat Oncol Biol Phys 2007, 67:828-833.
33. Crook J., Malone S., Perry G., Bahadur Y., Robertson S., Abdolell M. Postradiotherapy prostate biopsies: what do they really mean? Results for 498 patients. Int J Radiat Oncol Biol Phys 2000, 48:355-367.
34. Zelefsky M.J., Reuter V.E., Fuks Z., Scardino P., Shippy A. Influence of local tumor control on distant metastases and cancer related mortality after external beam radiotherapy for prostate cancer. J Urol 2008, 179:1368-1373.